Ocular Therapeutix™ Reports Positive Topline Clinical Data for the First of Two Phase 3 Clinical Trials Evaluating OTX-DP for the Treatment of Post-Surgical Ocular Inflammation and Pain

-- Topline results of the second Phase 3 clinical trial expected
by the end of March --

-- NDA submission anticipated in 2Q 2015 --

BEDFORD, Mass.--(BUSINESS WIRE)--Mar. 10, 2015--
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye, today announced positive topline
data from the first of two Phase 3 clinical trials evaluating the safety
and efficacy of its lead product candidate, OTX-DP (Sustained Release
Dexamethasone), for the treatment of ocular inflammation and pain
following cataract surgery. The Phase 3a study, which enrolled 247
patients, met both primary efficacy measures, achieving a statistically
significant improvement in the reduction of inflammatory cells and pain.
33.7% of OTX-DP-treated patients showed an absence of inflammatory cells
in the anterior chamber of the study eye on day 14 following drug
product insertion, compared to 14.6% of those receiving placebo vehicle
control punctum plug (p=0.0015). In addition, 76.1% of patients
receiving OTX-DP reported absence of pain in the study eye on day 8
following insertion of the drug product, compared to 36.1% of those
receiving placebo vehicle control punctum plug (p< 0.0001). Ocular is
continuing to analyze the safety findings from the clinical trial.

“This is an exciting day for Ocular Therapeutix as our sustained release
drug delivery platform continues to provide strong data in our clinical
trials in multiple indications,” said Amar Sawhney, Ph.D., President and
CEO. “The ability to administer the entire course of therapy for
post-operative inflammation and pain with a single dose would remove the
onus from patients to follow complex pharmaceutical dosing regimens
while providing the desired tapered therapeutic effect. If we also
achieve positive results in our Phase 3b clinical trial, for which we
expect to announce topline results by the end of March, we remain on
track to submit an NDA to the FDA for OTX-DP for post-surgical ocular
inflammation and pain in the second quarter of 2015.”

OTX-DP is a product candidate placed in the canaliculus and designed to
deliver dexamethasone to the ocular surface for approximately four
weeks. Following treatment, OTX-DP resorbs and exits the nasolacrimal
system without need for removal. In November 2014, the Company announced
encouraging data from its Phase 2 clinical trial evaluating the safety
and efficacy of OTX-DP in allergic conjunctivitis and the Company plans
to initiate Phase 3 clinical trials for this indication in the middle of
2015. The Company also initiated an exploratory Phase 2 clinical trial
of OTX-DP for the treatment of inflammatory dry eye in January 2015. The
Company is currently enrolling patients into a Phase 2b clinical trial
of its second sustained release product candidate, OTX-TP (Sustained
Release Travoprost), for the treatment of glaucoma and ocular
hypertension. Data from this trial is expected in the fourth quarter of
2015.

About the OTX-DP Post-Surgical Inflammation and Pain Clinical Trials

Two prospective, multicenter, randomized, parallel-arm, double-masked,
vehicle-controlled Phase 3 clinical trials, referred to as the Phase 3a
and Phase 3b clinical trials, were completed with a total of 487
patients (247 patients in Phase 3a and 240 in Phase 3b) undergoing
unilateral clear corneal cataract surgery. Patients were randomized 2:1
to receive either OTX-DP or a placebo vehicle control punctum plug
without active drug. Both primary efficacy measures, differences in the
proportion of patients in each treatment group with absence of cells in
the anterior chamber of the study eye, as measured using slit lamp
examination, at day 14 and absence of pain, as graded by a
patient-reported score of zero on a scale from zero to ten, at day 8
were recorded at each study visit. Secondary efficacy measures were
absence of flare in the anterior chamber of the study eye at each
evaluation date and absence of inflammatory cells in the anterior
chamber of the study eye and absence of pain in the study eye at each
evaluation date other than the day used for the primary efficacy measure.

Topline data from the Phase 3b clinical trial are expected to be
announced by the end of March. If the Company obtains favorable
aggregate results for both the Phase 3a and Phase 3b clinical trials,
the Company expects to submit a New Drug Application (NDA) for OTX-DP
for post-surgical ocular inflammation and pain in the second quarter of
2015. The Company believes that OTX-DP is the first sustained release
drug-eluting corticosteroid punctum plug to enter and complete Phase 3
clinical trials.

About Post- Surgical Ocular Inflammation and Pain

Ocular inflammation and pain are common side effects following
ophthalmic surgery. Physicians prescribe anti-inflammatory drugs, such
as corticosteroids, as the standard of care. If left untreated,
inflammation of the eye may result in further ocular complications,
including scarring and vision loss. Market Scope estimates approximately
5 million ocular surgeries will be performed in the United States in
2014.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the
development and commercialization of innovative therapies for diseases
and conditions of the eye using its proprietary hydrogel platform
technology. Ocular Therapeutix's lead product candidates are in Phase 3
clinical development for post-surgical ocular inflammation and pain, and
Phase 2 clinical development for glaucoma, allergic conjunctivitis, and
dry eye disease. The Company is also evaluating sustained-release
injectable anti-VEGF drug depots for back-of-the-eye diseases. Ocular
Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal
corneal incisions following cataract surgery.

Forward Looking Statements

Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the
development of the Company’s product candidates, such as the timing and
conduct of the Company’s Phase 3 clinical trials of OTX-DP for the
treatment of post-surgical ocular inflammation and pain, the potential
submission of an NDA for this indication, the potential utility of
OTX-DP for post-surgical ocular inflammation and pain, the timing and
conduct of the Company's Phase 2b clinical trial of OTX-TP for the
treatment of glaucoma and ocular hypertension and the Company’s Phase 3
clinical trials of OTX-DP for allergic conjunctivitis, the advancement
of the Company's other product candidates and other statements
containing the words "anticipate," "believe," "estimate," "expect,"
"intend", "goal," "may", "might," "plan," "predict," "project,"
"target," "potential," "will," "would," "could," "should," "continue,"
and similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important factors.
Such forward-looking statements involve substantial risks and
uncertainties that could cause the Company’s clinical development
programs, future results, performance or achievements to differ
significantly from those expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, those
related to the timing and costs involved in commercializing ReSure®
Sealant, the initiation and conduct of clinical trials, availability of
data from clinical trials and expectations for regulatory approvals, the
Company’s scientific approach and general development progress, the
availability or commercial potential of the Company’s product
candidates, the sufficiency of cash resources and need for additional
financing or other actions and other factors discussed in the “Risk
Factors” section contained in the Company’s most recent Quarterly Report
on Form 10-Q on file with the Securities and Exchange Commission. In
addition, the forward-looking statements included in this press release
represent the Company’s views as of the date of this release. The
Company anticipates that subsequent events and developments will cause
the Company’s views to change. However, while the Company may elect to
update these forward-looking statements at some point in the future, the
Company specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as representing the
Company’s views as of any date subsequent to the date of this release.

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